RU486 - THE FRENCH EXPERIENCE

RU486 (mifepristone) followed by a prostaglandin (PG) analogue has bee n marketed in France since April 1990 as a medical alternative to surg ery for early pregnancy termination. By law, the drug is used only in the centres approved for voluntary pregnancy termination, and its dist ribution is strictly controlled. Before being marketed, it was distrib uted to more than 20 000 women, as part of a training programme for th e prescribers. Analysis confirmed an efficacy rate of 95.3%. Failures included incomplete ovular expulsion (2.8%), premature vacuum aspirati on (0.7%) and ongoing pregnancy (1.2%). Pelvic pain and malaise were r eported as side-effects in 1.6 and 1.2% of the cases respectively. Inf ectious complications were reported in 0.2% of the cases. Three severe adverse events (one of which was fatal) occurred, including myocardia l infarction and ventricular arhythmia, in the hours following PG admi nistration and justify a careful medical monitoring in the centre 3-4 h after administration of PG. For this reason, a trial was undertaken to evaluate the efficacy of an oral form of a PGE(1) analogue (misopro stol). When RU486 was followed 36-48 h later by 400 mu g of misoprosto l, the efficacy rate was 96.9%, indicating an efficacy equivalent to t hat obtained with the other PG analogues. The distribution procedures were adequately followed by the prescribers and by the patients. In su mmary, RU486 constitutes a safe and efficient medical means of pregnan cy termination, provided that the manufacturer's recommendations are p roperly followed.